Mindset Medical has achieved a notable milestone with the U.S. FDA 510(k) clearance of its Informed Vital Core (IVC) App — a contactless, software-only medical device that measures respiratory rate using standard smartphone, tablet, or laptop cameras. This breakthrough follows the company’s earlier FDA clearance for a pulse rate measurement solution, reinforcing its vision to revolutionize telehealth through accessible, hardware-free monitoring technologies. By enabling vital sign detection through everyday devices, Mindset Medical is reshaping how and where patient care can occur.

The IVC App eliminates the need for physical contact or dedicated medical hardware, making it especially beneficial in telemedicine, outpatient facilities, long-term care, and home settings. The contactless feature enhances safety and comfort for patients, while significantly reducing the burden on healthcare providers. As telehealth becomes a lasting component of care delivery post-COVID, Mindset Medical’s solution offers a scalable, cost-effective tool for remote monitoring — empowering timely interventions without in-person visits.

This development marks a critical step forward in bridging healthcare accessibility gaps, particularly for underserved or immobile populations. With the ability to measure vital signs remotely and accurately, the IVC App supports earlier diagnoses, reduces hospital visits, and streamlines virtual consultations. Mindset Medical continues to expand its platform with clinician feedback at the core, aiming to deliver a seamless digital healthcare experience. This clearance not only validates the company’s innovation but also signals a future where technology plays an even greater role in proactive, patient-centered care.

MedTech Spectrum's Summary

FDA-Cleared Contactless Innovation: Mindset Medical’s IVC App, now FDA-cleared, allows respiratory rate monitoring via smartphone, tablet, or laptop cameras—eliminating the need for physical contact or dedicated hardware.

Enhanced Remote Care: The software empowers telehealth, home care, and long-term care settings with safe, accessible, and cost-effective vital sign monitoring, reducing strain on healthcare providers.

Scalable Digital Health Future: This milestone accelerates Mindset Medical’s mission to transform virtual care, enabling earlier interventions and greater healthcare access using everyday devices.